PENTASA 500 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

PENTASA 500 milligrams prolonged-release tablets

Mesalazine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Pentasa tablets are and what they are used for
2. What you need to know before you take Pentasa tablets
3. How to take Pentasa tablets
4. Possible side effects
5. Storage of Pentasa tablets
6. Contents of the pack and other information

1. What Pentasa tablets are and what they are used for

Pentasa tablets are indicated to help you stay free from new flare-ups of ulcerative colitis.

Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine is inflamed and develops many small breaks on its surface (ulcers) that can bleed.

Pentasa contains the active ingredient mesalazine, which belongs to a group of medicines called intestinal anti-inflammatory agents that help reduce inflammation and painful symptoms.

2. What you need to know before you take Pentasa tablets

Do not take Pentasa tablets:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to salicylates, for example aspirin.

• if you have severe kidney and/or liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pentasa tablets:

• if you are allergic to sulfasalazine (risk of salicylate allergy).

• if you currently have or have had liver or kidney function impairment
• if you have a disease that may make you prone to bleeding

• if you are taking treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have respiratory problems, particularly asthma.

• treatment should be discontinued immediately in case of cramps, abdominal pain, fever, severe headache, and rash.
• Kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough liquid during treatment with mesalazine.
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or sores in the mouth after using mesalazine

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Be careful with mesalazine:

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

If you experience severe or recurrent headache, vision changes, or ringing or buzzing in the ears, contact your doctor immediately.

While you are taking this medicine, your doctor will perform blood and urine tests to monitor your kidney function, especially at the start of treatment.

Use in people over 65 years:

It should be used with caution in people over 65 years and only in patients with normal kidney function.

Children and adolescents:

There is limited documentation on the effect in children (6-18 years). The dosage will be determined by your doctor.

Use of Pentasa tablets with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if you are taking any of the following medicines:

• azathioprine (used after transplants or to treat autoimmune diseases)

• 6-mercaptopurine or thioguanine (chemotherapy, used to treat leukemia)
• certain drugs that inhibit blood coagulation (medicines for thrombosis or to thin your blood).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited experience with the use of mesalazine during pregnancy and breastfeeding.

Blood disorders have been observed in newborns of mothers treated with this medicine. Newborns may develop allergic reactions after breastfeeding, for example, diarrhea. If the newborn has diarrhea, breastfeeding should be discontinued.

Fertility:

Data on mesalazine in animals show that it has no effect on male or female fertility.

Driving and using machines:

Treatment with Pentasa tablets does not seem to have any influence on the ability to drive and/or use machines.

3. How to take Pentasa tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is:

Adults:

To help you stay free from further flare-ups of colitis, your doctor may prescribe you generally 2 grams of mesalazine per day, administered in the form of 4 tablets once a day.

Use in children and adolescents (aged 6 years and above):

For children and adolescents, the dose will be calculated by your doctor based on body weight. The recommended dose in children and adolescents with a body weight of up to 40 kg will be half the usual recommended dose in adults, and for those children and adolescents with a body weight over 40 kg, the dose will be the same as the usual recommended dose in adults.

You should take the tablets whole orally(by mouth). To facilitate administration, they can be suspended in water or orange juice, shaken, and taken immediately.

If you think the effect of this medicine is too strong or too weak, tell your doctor.

If you take more Pentasa tablets than you should

No cases of overdose have been reported in humans, but if an overdose is suspected, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pentasa tablets:

Do not take a double dose to make up for forgotten doses.

If you stop taking Pentasa tablets

Your doctor will tell you how long to take Pentasa tablets. Do not stop treatment before, even if you feel better, as symptoms may return if treatment is stopped too soon. Follow your doctor's instructions strictly for the duration of treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pentasa tablets can cause side effects, although not everybody gets them.

Serious side effects:

Very few cases of severe allergic reaction (including severe skin erosion) have been reported. The allergic reaction could lead to swelling of the face and neck and/or difficulty breathing or swallowing (angioedema). If this happens, contact your doctor or emergency services immediately.

Tell your doctor immediately if you experience severe or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Stop taking mesalazine and seek medical attention immediately if you experience any of the following symptoms:

• red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin reactions are often preceded by fever or flu-like symptoms.

The following common side effectsaffect between 1 and 10 in every 100 patients treated:

• headache
• diarrhea
• nausea
• abdominal pain
• vomiting
• skin rash
• flatulence (gas)

The following rare side effectsaffect between 1 and 10 in every 10,000 patients treated:

• inflammation of certain areas of the heart (myocarditis and pericarditis) that can cause difficulty breathing and chest pain or palpitations (rapid or irregular heartbeat)
• inflammation of the pancreas (including symptoms of back and/or stomach pain) and increased amylase
• dizziness
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following very rare side effectsaffect less than 1 in every 10,000 patients treated:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduced red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia), which can increase the risk of infections or bleeding.
• liver disorders (characterized by symptoms including jaundice (yellowing of the skin and/or eyes) and/or pale stools).
• kidney disorders (symptoms include blood in the urine, edema (swelling due to increased fluid that can cause swelling of the ankles and increased blood pressure (nephritis))
• peripheral neuropathy (a condition that affects the nerves of the hands and feet, including symptoms of tingling and numbness)
• pulmonary and fibrotic allergic reactions (symptoms include cough, difficulty breathing, bronchospasm, bloody or excessive sputum)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that can affect several parts of the body, such as joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, unexplained bleeding (e.g., nosebleeds), bruising, purple skin discoloration, skin patches (including severe skin erosion and severe burns that can affect the skin as a protective barrier of the body)
• semen with low sperm concentration (oligospermia) (this is reversible)
• severe diarrhea and abdominal pain due to an allergic reaction to this medicine in the intestine
• allergic reactions and fever may occasionally occur

Frequency not known(cannot be estimated from the available data)

• kidney stones and associated kidney pain (see also section 2)
• change in urine color
• If you experience severe or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Some of these adverse reactions may also be attributed to the disease itself.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentasa tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month stated.

Do not store above 25°C. Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pentasa tablets

• The active ingredient is mesalazine. Each tablet contains 500 milligrams of mesalazine.
• The other ingredients are: Povidone, ethylcellulose, magnesium stearate, talc, microcrystalline cellulose.

Appearance and packaging of the product

Pentasa tablets are presented as grayish/brownish-white, round, speckled tablets, marked and engraved: 500 mg on one side, PENTASA on the other side.

They are available in double aluminum blisters of 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ferring S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturer:

FERRING GmbH

Wittland 11

24109 Kiel, Germany

Date of last revision of this leaflet: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/